NCT00002139

Brief Summary

To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Bacterial InfectionsHIV Infections

Keywords

Acquired Immunodeficiency SyndromeAzithromycinBacterial Infections

Interventions

AzithromycinDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Antiretroviral agents, provided regimen has been stable for at least 1 month.
  • Patients must have:
  • HIV infection.
  • CD4 count \<= 200 cells/mm3.
  • No active opportunistic infection (pending discussion with Pfizer Clinician).
  • Prior Medication:
  • Allowed:
  • Prior antiretroviral agents.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Active intercurrent illness (pending discussion with the Pfizer Clinician).
  • Allergies to macrolide antibiotics.
  • Signs and symptoms of severe illness that would preclude treatment.
  • Patients with the following prior conditions are excluded:
  • History of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
  • Clinically important change in baseline status within 4 weeks prior to study entry.
  • Condition affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies) within 4 weeks prior to study entry.
  • Prior Medication:
  • Excluded:
  • Investigational drugs including treatment IND drugs within 4 weeks prior to study entry.
  • Known drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ctr for Phase I Research

Wichita, Kansas, 67214, United States

Location

MeSH Terms

Conditions

Bacterial InfectionsHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-04

Locations

US(1)